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| Name | Class |
|---|---|
| Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte | OTHER |
| Rete Oncologica Piemonte, Valle d'Aosta | OTHER |
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This study aims to compare two different follow up regimens with different test intensity in endometrial cancer treated patients.
If eligibility criteria are satisfied and the written informed consensus is obtained, patients are stratified inside the centre according to their risk level:
In each group patients will be randomized in two regimens of follow up:
Features of each arm are listed in "Arms" item.
The procedure for centralized randomization, with blocks of variable length, will take place within each layer with 1:1 ratio and will be implemented within the centralized database, with sequences generated by dedicated software. The recruitment and randomization has to be registered on the website (www.epiclin.cpo.it) no later than 20 days after histological examination has been received. If patients do not need any kind of adjuvant therapy they will start follow-up program according to the regimen chosen for them at randomization, if adjuvant therapy is needed the patient at first will be registered and the randomization will be deferred at the end of treatment.
In presence of symptoms or signs detected during the clinical visit which may suppose a recurrence or in presence of abnormal tests, the clinician has to prescribe all medical tests and examinations required. The tests carried out in addition to follow-up scheduled program must be reported in the database. Nevertheless patients continue to be followed for the assessment of the performance status at 5 years, but the follow-up schedule is up to the clinician. An interim analysis is scheduled in 3.5 years starting from the beginning of recruitment (based on approximately 1 / 3 of the total expected events, when about 4 / 5 cases have already been enrolled). Patients will be stratified by recruitment Center, by level of risk (calculated according to the stage of the disease, the histotype and the grading) and by type of treatment performed.
The focus of the study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive follow up | Experimental | Intensive follow up in low-risk patients Intensive follow up in high-risk patients |
|
| Minimalist follow up | Experimental | Minimalist follow up in low-risk patients Minimalist follow up in high-risk patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive/Low-Risk follow up (IA G1; IA G2) | Procedure | - First 2 years of FU since the end of primary treatment: clinical visit* every 4 months; Pap tests; chest, abdomen, pelvis CT every 12 months - Since the third to the fifth year of FU: clinical visit* every 6 months; Pap test every 12 months * clinical visit with gynecological exploration |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Seven years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Seven years | |
| Proportion of complications, second cancers, co-morbidity | Seven years | |
| Proportion of asymptomatic patients with diagnosis of relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Zola, MD | Azienda Ospedaliera Città della Salute e della Scienza di Torino - University of Turin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Turin | 10100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19407561 | Background | Gadducci A, Fuso L, Cosio S, Landoni F, Maggino T, Perotto S, Sartori E, Testa A, Galletto L, Zola P. Are surveillance procedures of clinical benefit for patients treated for ovarian cancer?: A retrospective Italian multicentric study. Int J Gynecol Cancer. 2009 Apr;19(3):367-74. doi: 10.1111/IGC.0b013e3181a1cc02. | |
| 19407551 | Background |
| Label | URL |
|---|---|
| The recruitment of patients has to be registered on the website (http://www.epiclin.it). On the website patients are randomized and crf are available to register follow up appointment | View source |
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|
| Intensive/High-Risk follow up (≥ IA G3) | Procedure | - First 3 years of FU since the end of primary treatment: clinical visit*, Ca125, trans-vaginal and abdominal ultrasound every 4 months (except in conjunction with TC); Pap smear, abdomen, pelvis CT every 12 months - In the fourth and fifth years of FU: clinical visit*, Ca125, trans-vaginal and abdominal ultrasound every 6 months (except in conjunction with TC) Pap smear; chest, abdomen, pelvis CT every 12 months * clinical visit with gynecological exploration |
|
| Minimalist/Low-Risk follow up (IA G1; IA G2) | Procedure | - First 5 years of FU since the end of primary treatment: clinical visit* every 6 months. * clinical visit with gynecological exploration |
|
| Minimalist/High-Risk follow up (≥ IA G3) | Procedure | - First 2 years of FU since the end of primary treatment: clinical visit* every 4 months; chest, abdomen, pelvis CT every 12 months - Since the third to the fifth year of surveillance: clinical visit* every 6 months. * clinical visit with gynecological exploration |
|
| Seven years |
| Proportion of subjects who complete the two different regimes follow up | Seven years |
| Zanagnolo V, Minig LA, Gadducci A, Maggino T, Sartori E, Zola P, Landoni F. Surveillance procedures for patients for cervical carcinoma: a review of the literature. Int J Gynecol Cancer. 2009 Apr;19(3):306-13. doi: 10.1111/IGC.0b013e3181a130f3. |
| 17868785 | Background | Zola P, Fuso L, Mazzola S, Piovano E, Perotto S, Gadducci A, Galletto L, Landoni F, Maggino T, Raspagliesi F, Sartori E, Scambia G. Could follow-up different modalities play a role in asymptomatic cervical cancer relapses diagnosis? An Italian multicenter retrospective analysis. Gynecol Oncol. 2007 Oct;107(1 Suppl 1):S150-4. doi: 10.1016/j.ygyno.2007.07.028. Epub 2007 Sep 14. |
| 17466042 | Background | Zola P, Fuso L, Mazzola S, Gadducci A, Landoni F, Maggino T, Sartori E. Follow-up strategies in gynecological oncology: searching appropriateness. Int J Gynecol Cancer. 2007 Nov-Dec;17(6):1186-93. doi: 10.1111/j.1525-1438.2007.00943.x. Epub 2007 Apr 26. |
| 17291227 | Background | Gadducci A, Cosio S, Zola P, Landoni F, Maggino T, Sartori E. Surveillance procedures for patients treated for epithelial ovarian cancer: a review of the literature. Int J Gynecol Cancer. 2007 Jan-Feb;17(1):21-31. doi: 10.1111/j.1525-1438.2007.00826.x. |
| 38309033 | Derived | Rosato R, Ferrero A, Mosconi P, Ciccone G, Di Cuonzo D, Evangelista A, Fuso L, Piovano E, Pagano E, Laudani ME, Pace L, Zola P; TOTEM Collaborative Group. Impact of different follow-up regimens on health-related quality of life and costs in endometrial cancer patients: Results from the TOTEM randomized trial. Gynecol Oncol. 2024 May;184:150-159. doi: 10.1016/j.ygyno.2024.01.050. Epub 2024 Feb 3. |
| 35858170 | Derived | Zola P, Ciccone G, Piovano E, Fuso L, Di Cuonzo D, Castiglione A, Pagano E, Peirano E, Landoni F, Sartori E, Narducci F, Bertetto O, Ferrero A; TOTEM Collaborative Group. Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial. J Clin Oncol. 2022 Nov 20;40(33):3817-3827. doi: 10.1200/JCO.22.00471. Epub 2022 Jul 20. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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